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Cytochrome P450 2D6 (CYP 450 2D6) Genotype and Flecainide Efficacy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Assaf-Harofeh Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT00945867
First received: July 22, 2009
Last updated: April 4, 2011
Last verified: July 2009
History of Changes
  Purpose

The determination of the 2D6 genotype will enable us to determine the way flecainide is metabolized by the liver. Some individuals are poor metabolizers and some individuals are extensive metabolizers of the drug. This will also determine which patients will benefit from the drug.


Condition
Atrial Fibrillation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Use of CYP 450 2D6 Genotype as a Predictor of Flecainide Efficacy in the Treatment of Patients With Atrial Fibrillation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • no recurrence of atrial fibrillation [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the dose of flecainide used [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: September 2009
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Detailed Description:

Pharmacogenetics is the study of genetic variations on drug metabolizing enzymes and transporters. Pharmacogenetics is one of the first clinical applications of the Human Genome Project. Pharmacogenomics is the study of the role of interindividual genomics variability on drug response, efficacy, and metabolism. It correlates the effects of the entire expressed genome to the clinical usefulness and toxicity of a drug. Pharmacogenomics has the potential to change the way patients' therapy is optimized, allowing an era of "personalized medicine" in which patients will be divided into groups based on genetic markers that treatment outcomes.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with atrial fibrillation and a normal heart.

Criteria

Inclusion Criteria:

  • Patients with recurrent AF
  • Patients with a structurally normal heart
  • Patients > 18 YO
  • Patients who signed an informed consent

Exclusion Criteria:

  • Renal failure with creatinine clearance less than 40
  • Elevated liver enzymes 3 times the normal range, or causing coagulation test abnormality
  • Pregnant patients
  • Patients treated with psychiatric agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00945867

Contacts
Contact: Therese Fuchs, MD 972-8-977-8179 fuchst@asaf.health.gov.il

Locations
Israel
Assaf Harofeh Medical Center Not yet recruiting
Zrifin, Israel, 00000
Contact: Therese Fuchs, MD     972-8-977-8179     fuchst@asaf.health.gov.il    
Sub-Investigator: Moshe Sharist, MD            
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Study Chair: Moshe Sharist, MD Assaf-Harofeh Medical Center
Study Chair: Shmuel Bar-Haim, MD Assaf-Harofeh Medical Center
  More Information

No publications provided

Responsible Party: Therese Fuchs, MD, Assaf Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT00945867     History of Changes
Other Study ID Numbers: 111/09
Study First Received: July 22, 2009
Last Updated: April 4, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Assaf-Harofeh Medical Center:
flecainide
pharmacogenetics

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
 Flecainide
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013